Study of the Effect of Tranexamic Acid Administered to Patients With Hip Fractures. Can Blood Loss be Reduced?
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|ClinicalTrials.gov Identifier: NCT01535781|
Recruitment Status : Terminated (Recruiting slower than expected.)
First Posted : February 20, 2012
Last Update Posted : February 5, 2015
The effect of Tranexamic acid on blood loss, hemoglobin and transfusions in patients with pertrochanteric hip fractures.
Tranexamic acid is a well known drug used in many types of surgery. The investigators wish to investigate if the use of tranexamic acid can reduce the peri- and post-operative blood loss in patients who undergo surgery with a short intramedullary nail, for a pertrochanteric hip fracture.
An interim analysis was planned when reaching 60 inclusions. The interim analysis was conducted only on the primary outcome (TBL). A difference in TBL of no less than 500 ml was considered a reason to halt the study. The 0.001 level was chosen as a simple approach to this interim analysis from the Haybittle-Peto boundary
|Condition or disease||Intervention/treatment||Phase|
|Hip Fracture Anemia||Drug: Tranexamic Acid Drug: Placebo||Not Applicable|
Studies have shown that hip fractures have a hidden blood loss besides the recorded perioperative blood loss. Patients who are osteosynthesised with an intramedullary nail have been shown to have the largest hidden blood loss.
Postoperative anaemia is associated with a higher morbidity and mortality. We wish to investigate the possibility of reducing this hidden blood loss, with the use of a well known drug (tranexamic acid) that is widely used to reduce blood loss in other forms of surgery and in multitraumatized patients.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Tranexamic Acid on Blood Loss and Transfusion Need in Patients Operated With a Short Intramedullary Nail, for Pertrochanteric Fractures .|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||August 2014|
Placebo Comparator: Placebo
Patients are given saline instead of tranexamic acid in the placebo group
Identical syringe and drip used as in the intervention, to ensure blinding.
Other Name: Saline
Active Comparator: Tranexamic Acid
Tranexamic acid; 1 gram as a bolus prior to surgery. 3 grams of Tranexamic acid in 1 liter of saline as a 24 hour infusion.
Drug: Tranexamic Acid
1 g of tranexamic acid as a bolus immediately before surgery 3 g of tranexamic acid in 24hours postop.
Other Name: Cyklokapron (tranexamic acid)
- Total Blood Loss [ Time Frame: time in hospital (approximately 10 days) ]Calculated as described by Foss et al in their study of 2006. "Hidden Blood Loss After Surgery for Hip Fracture" JBJS br. 2006.
- Transfusions [ Time Frame: From admission to third day after surgery. ]Information from local blood bank
- Mortality [ Time Frame: 30 days and 90 days follow up ]Mortality is obtained via central personal registration system (Danish CPR system)
- Thromboembolic Event (clinical, NOT by routine ultrasound measurement) [ Time Frame: 90 days follow up ]Obtained in-hospital, through routine check ups daily. After discharge; obtained from patient records.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01535781
|Hvidovre, Copenhagen, Denmark, 2650|
|Principal Investigator:||Peter T Tengberg, MD||Hvidovre University Hospital|
|Study Chair:||Henrik Palm, MD||Hvidovre University Hospital|
|Study Director:||Anders Troelsen, PhD||Hvidovre University Hospital|
|Study Chair:||Michael Krasheninnikoff, MD||Hvidovre University Hospital|
|Study Chair:||Nicolai B Foss, PhD, Dr.Med||Hvidovre University Hospital|